NCT02598817已完成不适用
Acceptability of "High Sn-2" Infant Formula in Non-Breast Fed Healthy Term Infants Regarding Gastrointestinal Tolerability by Both Parents and Pediatrician. An Open Label Pilot Study Evaluation in the Gulf Cooperation Council (GCC) Countries.
Société des Produits Nestlé (SPN)5 个研究点 分布在 2 个国家目标入组 276 人开始时间: 2018年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 276
- 试验地点
- 5
- 主要终点
- Infant Stool Form Scale
研究概览
简要总结
The purpose of this study is to evaluate the effects of term infant formula containing high 2-palmitic vegetable oil on stool composition, stool characteristics and gastrointestinal (GI) Tolerance.
详细描述
This is a multicenter, open label, observation study; 500 formula fed infants are planned to be enrolled from a network of general pediatricians in the Gulf countries (UAE, Kuwait, Qatar, and KSA). Eligible infants will consume a high sn-2 palmitate infant formula for 12 weeks. All enrolled infants will be evaluated at enrollment and at 4 weeks and 12 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Weeks 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Formula fed healthy full term infants with normal birth weight (2500g 4000g)
- •Partially breast and formula fed infants who drink at least 2 formula feedings per day; each to be at least 30ml
- •Infants of both genders at age of 2 weeks to 12 weeks
- •Infants of parents providing written informed consent before any study related activities are carried out
排除标准
- •Preterm or IUGR babies
- •Contraindication of standard infant formula
- •Infants who have allergy of cow's milk protein
- •Infants with Serious medical or surgical GI disease
- •Infants with multiple congenital anomalies
- •Infants with suspected chromosomal or metabolic disorder
- •Infants of mothers with a health condition or socioeconomic problems that may interfere with their ability to take care of their infants
- •Infants of parents who refuse to participate in the study
结局指标
主要结局
Infant Stool Form Scale
时间窗: 12 weeks
frequency and consistency
次要结局
- Changes from baseline to 12 weeks in Height centile(12 weeks)
- Changes from baseline to 12 weeks in Weight centile(12 weeks)
- Changes from baseline to 12 weeks in Head Circumference centile(12 weeks)
研究者
研究点 (5)
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